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FDA Advisors Vote That Benefits Of Abbott’s MitraClip Outweigh Risks

The agency’s Circulatory System Devices Panel narrowly voted in favor of Abbott’s MitraClip transcatheter mitral valve repair system to reduce mitral regurgitation. But the discussions about the clinical evidence on the technology were complex and the panel’s support for Abbott’s PMA was not unanimous.

FDA’s Circulatory System Devices Advisory Committee voted 5-3 in favor of Abbott Vascular’ MitraClip percutaneous mitral valve repair device at its March 20 meeting in Gaithersburg, Md.

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• By Brian Bossetta

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Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

 
• By Elizabeth Orr

The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.

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• By Marion Webb

Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.